Last Week Tonight in BioPharma: Week of July 27th, 2026
Novo's IL-6 fails to curb CV events, new life for Replimune, and ArgenX makes an acquisition
Welcome back to Last Week Tonight in BioPharma (LWTB). What a week!
This week, Replimune scored a 10-3 AdComm win for RP1 in melanoma, Novo Nordisk watched its $2.8B IL-6 cardiovascular bet go down in a Phase 3 flame, and argenx dropped $2.2B to grab a CD122 antibody that could expand its immunology footprint well beyond VYVGART.
All that and more below. Let’s get into it!
📡 PRESS RELEASE DECODER
What the press releases actually mean
Novo Nordisk’s $2.8 Billion IL-6 Bet Fails in Phase 3 ZEUS: Ziltivekimab Cuts Inflammation but Does Not Cut Cardiovascular Events
📅 July 31, 2026 | 🏢 Novo Nordisk ( NVO 0.00%↑ ) | 💊 ziltivekimab | 📋 Phase 3 Trial Failure (ZEUS)
Novo Nordisk announced July 31 that ziltivekimab missed the main goal of the Phase 3 ZEUS trial, failing to show it prevented heart attacks, strokes, or cardiovascular death in people with chronic kidney disease or atherosclerotic coronary artery disease. The drug did lower IL-6 and high-sensitivity C-reactive protein as expected, but those biomarker reductions did not translate into clinical event reduction. Novo’s shares fell as much as 10% on the news.
ZEUS enrolled more than 6,000 patients with elevated hsCRP levels who were randomized to ziltivekimab or placebo and followed for up to four years. The hypothesis was that blocking IL-6 would reduce hsCRP and thereby protect heart health, extending the logic of prior inflammatory cardiovascular trials including CANTOS with canakinumab. Novo gained ziltivekimab through its 2020 acquisition of Corvidia Therapeutics, for which it paid $725 million upfront with up to $2.1 billion in total payouts.
Novo said it will take a non-cash impairment charge in Q3 but will not need to change its operating profit guidance. Two other ziltivekimab trials, in heart failure and post-acute heart attack populations, are ongoing with results expected in 2027.
🧠 BPS Take: Ziltivekimab worked mechanistically, cutting both IL-6 and hsCRP, but that reduction did not translate to fewer deaths and heart attacks. This is the same question that has haunted the inflammatory cardiovascular hypothesis since the CANTOS trial showed canakinumab could reduce events but only at the cost of meaningful infection risk. What ZEUS hints at is that simply blocking a cytokine to reduce hsCRP isn’t good enough to reduce heart attacks. Or in other words, perhaps blunting the source of inflammation (e.g. lipids, plaques, etc.) is more important than blunting the inflammation itself.
The cardiovascular community will spend the next year arguing about whether the enrolled population was too late-stage, whether four years was long enough, or whether the IL-6 pathway is simply the wrong lever in these patients. The bigger casualty is the broader hsCRP-reduction thesis that several development-stage biotechs had been building on. BioAge’s 65% intraday drop tells you everything you need to know about how investors are repricing that mechanism risk today.
For Novo, this is painful but contained. The GLP-1 franchise generates enough cash to absorb a writedown without existential consequence. The two remaining ziltivekimab trials in different populations still run, but there shouldn’t be much weighing on those outcomes. They have been relatively quiet on the business development front, especially compared to Lilly, so perhaps the “clearing of the deck” of some of these internal programs could prompt Novo to be more aggressive in M&A.
Altimmune’s Pemvidutide Delivers Positive Phase 2 Data in Alcohol Use Disorder
📅 July 28, 2026 | 📊 Altimmune ( ALT 0.00%↑ ) | 💊 pemvidutide | 📋 Phase 2 Trial Win (RECLAIM)
Altimmune reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide, its once-weekly dual GLP-1/glucagon agonist, in alcohol use disorder (AUD). Pemvidutide 2.4 mg drove an average of 4.2 fewer heavy drinking days per week over 24 weeks vs. baseline, compared to a 2.75-day reduction on placebo — a statistically significant win on the primary endpoint. The drug also beat placebo on WHO Risk Drinking Level reduction, abstinent days, and delivered a 38% drop in serum phosphatidylethanol (vs. +5.9% for placebo), a direct biomarker of alcohol consumption. Safety was consistent with prior pemvidutide studies; five patients discontinued for GI-related AEs vs. zero on placebo. Altimmune plans to meet with FDA to discuss a pivotal path.
🧠 BPS Take: These data further validate the the therapeutic relevance of GLP-1 based mechanisms in curbing alcohol consumption. Lilly is probably quite pleased to see this positive signal in their competitors data, as they gear up for P3 data of brenipatide, the company’s once-monthly GLP-1/GIP agonist. It is still unclear how specific this anti-addiction effect is for GLP-1s. Do they simply down-regulate addictive behaviors broadly? Is this more a down-dialing of desire generally? Is this more a food-related/calorie-seeking effect, because alcohol is caloric like food is? All those questions will help elucidate how this aspect of GLP-1s work in the human mind.
For a longer take on brenipatide and why I think it may be the most impactful GLP-1 yet, see The GLP-1 You Probably Haven’t Heard Of.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
Replimune’s Three-Time Reject Beats the AdComm: RP1 Gets a 10-3 Vote and a Final Decision Date of August 2
📅 July 30, 2026 | 🏢 Replimune ($REPL) | 💊 RP1 (vusolimogene oderparepvec) plus nivolumab | 📋 FDA Advisory Committee Vote
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 on July 30 that efficacy results from Replimune’s IGNYTE study on RP1 combined with nivolumab are evaluable and clinically meaningful. The vote is non-binding, but the FDA is set to issue a decision by August 2 on a drug it has now rejected twice.
IGNYTE is a single-arm trial in patients with anti-PD-1-resistant advanced melanoma, a population where response rates to standard therapy are poor. Replimune reported an overall response rate of 33.6% in the full study population. FDA scientists pushed back hard in their briefing documents, arguing that when excluding patients without non-injected target lesions to assess systemic response, the ORR dropped to 15.7%. The agency’s concern is that the trial design made it difficult to distinguish RP1’s systemic effect from the local effect of direct tumor injection, and that deviations from RECIST v1.1 guidelines inflated the apparent response rate.
The majority of panelists disagreed. Hussein Tawbi of MD Anderson Cancer Center, voting in favor, said: “In my mind, this should be a therapy that’s available to patients in the short term until the Phase 3 trial reads out.” A confirmatory Phase 3 trial is expected to produce results in late 2027. Were the FDA to reject RP1 again, Replimune would need those results before making another submission.
Replimune’s resubmission reportedly came after White House intervention, a detail reported by the Wall Street Journal. The company had previously claimed a prior review team had found adequate evidence of efficacy, which the Makary-Prasad era FDA then reversed.
🧠 BPS Take: Well this Replimune story continues to be interesting. When the FDA flagged inconsistencies in the trial protocol and response measurement, it made it seem like Replimune was manipulating the data in their favor. That paired with a mudslinging PR campaign against the FDA gave me pause about RP1s chances. But this is exactly why adcoms are incredibly valuable. You have a major divide between the way the FDA sees RP1 and the way Replimune sees RP1. Convene a group of experts from diverse backgrounds to ask questions and provide their perspectives on what RP1s path should be and what value this new regimen could add for patients.
The Prasad-Makary era’s unwillingness to even have an adcom looks quite obstructive in retrospect. This was clearly a complicated case that required some public airing out. Is there evidence of abscopal effect? Does PD-1 retry in a post-PD-1 population work? Should RP1 have been used as monotherapy in the P2 design? What’s the correct way to measure response for an intratumoral therapy? The answers to those questions shouldn’t be set in stone by one person. It requires legitimate debate weighed against benefit-risk of this drug regimen for patients.
Holding this adcom so close to the PDUFA date is an odd one for sure. I would guess that the PDUFA date gets pushed back. Given the response discrepancy between the FDA and Replimune analysis, I have a really hard time seeing them come to terms about what goes into the label within a couple days. What that label looks like and how restrictive it is will influence RP1’s uptake (assuming it is approved) and how clean a launch they can have in the post-PD-1 setting. Given the FDA sees this as only a 15% ORR type of product, the Replimune on-label efficacy could look quite a bit smaller than the 33% the company is hoping for.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
Argenx Pays $2.2 Billion for Forte’s FB102, Betting a Phase 1b CD122 Antibody
📅 July 27, 2026 | 🏢 Argenx ( ARGX 0.00%↑ ) | 💊 FB102 (anti-CD122 monoclonal antibody) | 📋 M&A Acquisition
Argenx agreed on July 27 to acquire Forte Biosciences for $77 per share in cash, representing a total equity value of approximately $2.2 billion. The deal reflects an approximately 86% premium to Forte’s volume-weighted average price since July 9, 2026, when Forte reported positive Phase 1b data in vitiligo. The transaction is funded entirely from argenx’s cash on hand, carries no financing condition, and is expected to close in Q3 2026.
The acquisition centers on FB102, a first-in-class anti-CD122 monoclonal antibody with clinical proof-of-concept in vitiligo and celiac disease. Phase 2 data in celiac disease is expected in the second half of 2026. Phase 1b data in alopecia areata is also expected in 2026. CD122 is a receptor subunit shared by the IL-2 and IL-15 receptor complexes, and blocking it modulates memory T cells that are implicated in multiple autoimmune conditions. Teva Pharmaceutical and First Tracks Biotherapeutics have similar drugs in clinical development.
Argenx had participated in a $150 million Forte stock offering in April 2026, signaling early interest. The company’s CEO Karen Massey described FB102 as aligning with “the argenx playbook: compelling biology, strong clinical validation and broad potential.” VYVGART, argenx’s anchor product, generated close to $2.9 billion in revenue in the first half of 2026 and already has approvals in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
🧠 BPS Take: Don’t look now, but argenx is a $50B company with a major commercial engine in neuro-immune/inflammation. Bringing in the Forte asset builds on VYVGART’s commercial foundation and enables argenx to expand into new autoimmune areas like celiac and skin.
This acquisition continues a lengthening line of BioPharma middleweights becoming buyers of small biotechs. We have a growing set of companies that are commercial stage specialty players that are too big to be taken out by Big BioPharma. This group, headed by argenx, is now turning its attention outside its walls for R&D. Some other recent examples include Genmab x Merus - $8B, Biomarin x Amicus - $4.8B, Neurocrine x Soleno - $2.9B, and UCB x Candid & Neurona - $2.2B & $1.15B. I think we will see more names in this class (RevMed, Insmed, Jazz, etc.) become buyers over the next twelve months, competing with Big BioPharma for names in the sub-$8B-ish range. I am curious to see if names like Moderna and Alnylam also enter the fray, as their strategies are far more platform centric, thus limiting the pool of available target companies.
DISCLAIMER: Alright, legal department says I gotta say this: nothing in this post is financial, medical, legal, or any-other-kind-of advice. I’m just a guy on the internet with opinions, a penchant for clinical data, and an unhealthy obsession with BioPharma strategy. All views, opinions, and analyses are solely the work product of me and Big Pharma Sharma LLC — not my employer, clients, friends, associates, or anyone else who has ever been in the same meeting room as me. Do I have opinions on these companies, deals, and drugs? Obviously. Should you trade, invest, prescribe, or make life decisions based on them? Absolutely not. Manage your portfolio however you want, talk to actual licensed professionals, and please don’t hold me — or anyone adjacent to me — accountable when biotech does biotech things. You’ve been warned.